To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma
Since currently there is no standard therapy for untreated advanced-stage low-grade B-cell lymphoma, Phase 2/3 study was planned. Comparison(s): An intensified bi-weekly version by shortening the intervals of both rituximab and CHOP therapies using G-CSF, compared to the tri-weekly R-CHOP regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Rituximab + Standard CHOP
Rituximab + Bi-weekly CHOP
CR rate (phase II)
Time frame: during the study conduct
PFS (phase III)
Time frame: during the study conduct
ORR, PFS, OS, Safety (phase II)
Time frame: during the study conduct
OS, Safety (phase III)
Time frame: during the study conduct
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Aichi Medical University
Aichi-gun,Nagakute,Yazako,Karimata,21, Aichi-ken, Japan
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1, Aichi-ken, Japan
Nagoya University School of Medicine
Nagoya,Showa-ku, Tsurumai-cho,65, Aichi-ken, Japan
Nagoya Daini Red Cross Hospital
Nagoya,Showa-ku,Myoken-cho,2-9, Aichi-ken, Japan
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aich, Japan
Akita University School of Medicine
Akita,Hondo,1-1-1, Akita, Japan
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
Ehime University Hospital
Shitsukawa,Toon, Ehime, Japan
...and 35 more locations